Purrble With LGBTQ+ Youth Who Have Self-harmful Thoughts

NCT06025942 | Completed DMC

• 1 other identifier: RESCM-22/23-34570
• Study Type: interventional
• Target: 155
• Locations: 1 country
• Sites: 1

Brief Summary

The primary aim of the proposed Randomised Control study is to investigate the effects of a socially assisted robot (i.e. Purrble) on emotional regulation difficulties (measured by DERS8) with young LGBTQ+ people who have self-harmful (with or without suicidal intention) (in comparison to a wait-listed control). Secondary aims include investigating the effects of the Purrble on young people's self-harmful thoughts, symptoms of anxiety and depression, alongside quantitative and qualitative (interviews) measures of engagement with the intervention.

Conditions

Emotion Regulation; Self Harm

Keywords

LGBTQ; Self-harm; Emotion regulation; Young people; RCT

Outcome Measures

Primary Outcomes (1)

• Emotion regulation (DERS8)

  Across the trial, we hypothesise that access to the Purrble intervention (compared to the waitlist control) will lead to a decrease in self-reported difficulties with emotion regulation as measured by the primary outcome (DERS8). We will compare the DERS8 assessment pre-deployment (calculated as the average of DERS scores across baseline weeks 1-3) and final deployment assessments (averaged across weeks 11-13). Measured by: Difficulties with Emotional Regulation Scale-8 (DERS8), an 8-item instrument used to measure or assess the difficulties with regulating emotion \[22\]. The DERS8 score is calculated using a 5-point Likert scale, ranging from 1 (almost never, 0-10%) to 5 (almost always 91-100%). These scores are added together to form a total score (8-40). Higher scores indicate greater levels of difficulty associated with response to situations eliciting negative emotions.

  all timepoints [Time Frame: Three times during pre-deployment (week 1-3) and ten times during the 10-week long deployment period (week 4-13) = total of 13 times]

Secondary Outcomes (3)

• Self-harmful thoughts (SHQ)

  all timepoints [Time Frame: Three times during pre-deployment (week 1-3) and ten times during the 10-week long deployment period (week 4-12) = total of 13 times]

• Anxiety (GAD7)

  all timepoints [Time Frame: Three times during pre-deployment (week 1-3) and ten times during the 10-week long deployment period (week 4-13) = total of 13 times]

• Depression (PHQ-9)

  all timepoints [Time Frame: Three times during pre-deployment (week 1-3) and ten times during the 10-week long deployment period (week 4-13) = total of 13 times]

Other Outcomes (5)

• Emotion regulation (PMERQ)

  3 timepoints [Timeframe: Once during pre-deployment (week 3 [T0]) and twice during the 10 -week long deployment period (week 8 [T5], week 13 [T10]) = total of 3 times]

• Hopefulness (SHS)

  [Timeframe: Once during pre-deployment (week 3 [T0]) and twice during the 10 -week long deployment period (week 8 [T5], week 13 [T10]) = total of 3 times]

• Loneliness (UCLA)

  3 timepoints [Timeframe: Once during pre-deployment (week 3 [T0]) and twice during the 10 -week long deployment period (week 8 [T5], week 13 [T10]) = total of 3 times]

Study Arms (2)

Intervention

EXPERIMENTAL

The Purrble intervention takes the form of an interactive plush toy, designed to be handed over to the young person and support in-the-moment soothing.

Behavioral: Purrble intervention

Control

NO INTERVENTION

Wait-list control (access to services as usual)

Interventions

Purrble intervention BEHAVIORAL

When the Purrble is picked up, it emits a frantic heartbeat that slows down if the person uses calm stroking movements. If the Purrble is soothed for long enough, it transitions into a purring vibration indicating a calm, content state. Logic model underlying the intervention: Level 1: in-the-moment soothing support to young people in emotional moments when they would attempt to utilise emotion regulation (ER) strategies to calm down. Level 2: mechanisms that facilitate long-term engagement with the intervention, building on positive subjective experience of Level 1. Level 3: shift in young peoples' ER practices and implicit beliefs about emotion, after repeated experience of Levels 1-2. * see JMIR Res Protoc 2021;10(11):e28914 (doi: 10.2196/28914)

Intervention

Eligibility Criteria

• Age: 16 Years - 25 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Currently experiencing self-harmful thoughts (within the last month) Identify as sexual orientation or gender identity minority (LGBTQ+) Aged 16-25 years Currently living in the UK at the time of the study Able to read and write in English

You may not qualify if:

• Young people who live outside the UK, are not within the 16-25 year age bracket, and are not experiencing self-harmful thoughts will not be included in the study.

Sponsors & Collaborators

• King's College London: lead
• University of Oxford: collaborator
• University of Nottingham: collaborator
• University of Glasgow: collaborator
• Stanford University: collaborator
• University of Melbourne: collaborator

Study Sites (1)

King's College London

London, United Kingdom

Location

Related Publications (26)

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  PMID: 38195171 DERIVED

MeSH Terms

Conditions

Emotional Regulation; Self-Injurious Behavior

Condition Hierarchy (Ancestors)

Self-Control; Social Behavior; Behavior; Behavioral Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 29, 2023
• First Posted: September 6, 2023
• Study Start: January 11, 2024
• Primary Completion: October 23, 2024
• Study Completion: March 1, 2025
• Last Updated: March 4, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ANALYTIC CODE
• Time Frame: Access to the data will be available once the trial is complete. Trial end date is currently September 2025
• Access Criteria: Reasonable requests for access to the data will be reviewed by core study team

Locations

GB (1)